Principal Investigator/Program Director (Last, First, Middle): Greenberg, Harry B. Program Function 8 RESEARCH EDUCATION AND TRAINING A. INTRODUCTION AND TRANSFORMING INTENT For the past five years, the overarching mission of the Stanford University School of Medicine (SoM) has been the translation of discoveries into medical practice. A plan developed in 2001-02 has encouraged transforming efforts in clinical and translational (CT) education and research by providing the resources to support such endeavors. The vision and goals of this plan, Translating Discoveries, are closely aligned with those of the NIH Clinical and Translational Science Award (CTSA) effort. The CTSA program has given the SoM an important opportunity to reassess, refine and refocus these efforts and move to another level in our effort to transform the practice of CTR across the University. The result will be an administrative home, the Stanford Center for Clinical and Translational Education and Research (SCCTER, pronounced ske-ter), which will totally reshape and focus our efforts in enabling and accelerating translational medicine while minimizing overlap and maximizing efficiency. More specifically, we have made substantial strides in creating enhanced education and training opportunities in clinical and translational research (CTR). Three examples of new and innovative educational initiatives include our scholarly concentrations for medical students, our multidisciplinary Biodesign program for engineers, physicians and other biomedical investigators, and our Masters of Science in Medicine (MOM) degree for PhD candidates. The scholarly concentration program is embedded in our new medical student curriculum. Of the seven concentrations, the two most popular (clinical research and community health) are directly relevant to CTR education and training. Our Biodesign program represents a unique CTR training opportunity built around teams of physicians, engineers, and postgraduate students learning how to successfully invent medically useful devices. Our MOM degree affords PhD candidates at Stanford the opportunity to matriculate with our first and second year medical students, integrating their basic science training with the critical foundations of health and human disease and the practice of medicine to provide these students a more fundamental understanding of translational and clinical medicine. In addition to these three recent initiatives, we are attempting to address the future need for well-trained CT researchers by engaging students earlier in their educational pathway. For example, we host several summer science enrichment courses for gifted and disadvantaged high school students. We consider it essential to reach out specifically to low-income and ethnic minority youth, because they are often overlooked by outreach programs. We also are making efforts to encourage more Stanford University undergraduate students to enroll in seminar courses directed by faculty with research interests in CTR and to increase opportunities for these students to work on human health related research projects with our faculty. Early exposure to CT education and training programs will encourage more of these students to consider a CTR-related profession. Numerous didactic courses have been developed by many of our CTR stakeholders, including the Department of Health Research and Policy, several clinical departments, the Office of Postdoctoral Affairs, the General Clinical Research Center (GCRC, now the Clinical and Translational Research Unit, Program Function 4), the Center for Biomedical Ethics, and the Stanford/Packard Center for Translational Research in Medicine (SPCTRM, now the Support Portal, Program Function 3). In addition, our NIH-funded training programs related to CTR (Table 8.1), including 22 T32s, 4 R25s, and 3 K12s, each have developed many seminar courses and journal clubs. Furthermore, all trainees and faculty have access to Masters degree programs in Epidemiology, Health Services Research, and Public Policy, on our campus, and we have a joint MPH program with the School of Public Health in Berkeley. Other joint degree opportunities are available across the University in the School of Humanities and Science (Biological Sciences and Biophysics), the School of Engineering (Bioengineering, Biomedical Informatics, and Biomechanical Engineering), the Graduate School of Business, and the School of Law. Despite our rich educational environment and concerted efforts to develop a wide range of discipline- specific and interdisciplinary education and training programs, the preparation of this application has stimulated the development of a plan for accelerated improvement. This plan, described below, has PHS 398/2590 (Rev. 09/04, Reissued 4/2006) Page 592 Continuation Format Page Principal Investigator/Program Director (Last, First, Middle): . Greenberg, Harry B. resulted from a faculty-wide survey and deliberations of a CT Education and Training planning committee. The overall goals of our plan are: [unreadable] To utilize the considerable faculty and student talent at all seven of Stanford's Schools to improve CT research and education across the enterprise [unreadable] To recruit, educate, and train a continuum of outstanding future CT investigators [unreadable] To promote awareness of the value and necessity of multidisciplinary and interdisciplinary team research [unreadable] To facilitate and coordinate all of our education and training initiatives in the area of CTR. CTR at Stanford has been carried out primarily by faculty at the SoM, with limited but very fruitful interactions with faculty in our other Schools. Our first goal is designed to apply the expertise at Stanford's seven Schools to CTR by educating faculty and trainees at our other Schools in the importance and methodology of CTR. Conversely, we also will utilize the considerable expertise at the other Schools to help educate the next generation of CT investigators in the SoM. The CTSA will allow us to develop programs to facilitate this cross-School and cross-discipline pollination;this will be transformative for CT research and education at Stanford and, potentially, in the country. Our second goal, to support a continuum of trainees, is critical for several reasons. Engaging trainees early in their career will encourage them to pursue careers in CTR, thereby ensuring the development of a steady pipeline of CTR investigators. Trainees along the continuum will be able to assist the next tier of trainees by acting as near-to-peer role models. Trainees late in the continuum will develop leadership skills while assuming oversight responsibilities for more junior colleagues. The continuum also will provide a defined pathway, from novice to expert, affording trainees the opportunity to increase their level of knowledge and expertise as they advance academically. Our third goal is to conduct meaningful multidisciplinary exercises that include affiliated nurse scientists and allied health researches, and to build research projects that will encourage and foster collaborations both within and outside the SoM. Since translational medicine is both interdisciplinary and multidisciplinary by nature, a comprehensive educational program should include participation of students from both the MD and PhD pathways and should integrate these programs so that trainees receive maximum exposure to other disciplines. We plan to teach this multidisciplinary approach through participation in our six-week team-building practicum exercises. These teams will be composed of members from multiple disciplines with varied educational backgrounds. Our fourth goal, to facilitate and coordinate all current education and training initiatives, will be critical to supporting our continuum of trainees, building our multidisciplinary programs, and eliminating unnecessary duplication of efforts. A key component of this goal is to take advantage of "teachable moments" in the study design process (Program Function 3: Support Portal) as opportunities for training and as sources of didactic material. , A.1. Innovation The organization and structure of the education and training programs that we propose will transform the CTR learning environment at Stanford through an integrated and cross-pollinating design. We will recruit professionally diverse trainees along the continuum from high school students to junior faculty, with special outreach to under-represented young adults, and with multiple interactions between the training levels. We will foster individual and collaborative learning by creating innovative multidisciplinary teams. We will support innovation by creating new advanced degree programs at the Masters- and PhD-level; these programs will train MD and PhD investigators who understand the importance of, and methods for, translating basic scientific discoveries into improved human health for the community at large. Most importantly, we will bring the greater Stanford community's considerable assets and expertise to bear on CTR and CTR-related education. B. SPECIFIC AIMS Our CTR Education, Training, and Career Development Programs will address the critical shortage of well-trained CT investigators and the need for multidisciplinary CTR teams by devoting programs to each level of trainee. Our five specific aims are: Aim 1. To engage the broader Stanford University community in CTR education, training, and career development. PHS 398/2590(Rev. 09/04, Reissued 4/2006) Page 593 Continuation Format Page Principal Investigator/Program Director (Last, First. Middle): Greenberg, Hairy B. Education and training in CTR at Stanford University primarily has involved pre- and postdoctoral students in the SoM. Although Stanford does not have other health professional Schools, such as nursing, dentistry and pharmacy, we do have world class discipline-specific Schools of engineering, law,business, earth sciences, education, and humanities and science, as well as a strong tradition of Interdisciplinary Centers that leverage expertise across the campus to approach specific interdisciplinary subjects such as CTR. With CTSA funding and the development of SCCTER, we intend to develop programs and projects that increase the interconnectedness of students and faculty across the seven Schools of our University with the goal of bringing the broad interdisciplinary expertise available at Stanford to bear on CT research and education. Aim 2. To develop a T32 predoctoral comprehensive CTR training program that will include an MS in Medicine and an MS and PhD in Epidemiology or Health Services Research. The objective of Stanford's Predoctoral Clinical Research Training Program will be to provide the environment and educational infrastructure that will offer medical students and PhD candidates an understanding of, experience with, and appreciation for, CTR. This program also will support their training in the principles and practice of CTR. The program will offer students of varied professional backgrounds the knowledge and skills necessary to: [unreadable] Understand how basic laboratory discoveries can be translated into clinical application and how critical clinical problems can be identified and cycled back to the bench for solution [unreadable] Appreciate how basic science tools can enrich the design and conduct of clinical research [unreadable] Comprehend the scientific principles underlying the design, conduct, and analysis ofCTR [unreadable] Understand the public health issues, and how epidemiology and health services research can complement clinical research [unreadable] Understand the process by which important research findings are translated into best practices and how these practices can be most effectively introduced into the community [unreadable] Realize the value of conducting research as members of interdisciplinary teams [unreadable] Appreciate problems faced by research study patients both before and during a study The predoctoral training program will be comprised of several components including: Masters of Medicine (MOM) for PhD students, Scholarly Concentrations for medical students, Masters and PhD degrees in Epidemiology and Health Services Research, and a design team program. Aim 3. To foster resident interest in careers inCTR. The decision to pursue a career in CTR often is made during residency training. However, because residency is heavily focused on the mastery of clinical skills, there is limited time to participate in clinical research education programs or to conduct research projects. We will transform the traditional residency training experience to stimulate and foster resident interest in CTR by: (1) embedding CTR education in residency curricula, (2) offering a one-week intensive CTR course, and (3) developing a pilot program in the Department of Pediatrics that affords the opportunity for meaningful research involvement during residency. Aim 4. To support the development of both MD and PhD scientists interested in careers in CTR. The overarching goal of our proposed K12 program is to recruit MD and PhD postdoctoral trainees into a multidisciplinary CTR training program that stimulates their interest in academic careers in the field. The proposed training will provide candidates with strong mentorship, didactic training in clinical research methodologies, and practical research and writing experience. To realize their full potential, CTR Scholars will be trained to work in close collaboration with partners from different fields. This has become increasingly important as the methodology of clinical research has become substantially more sophisticated and the tools to produce, manage and analyze resulting scientific data have become more powerful and complex. Additional challenges have resulted from the proliferation of regulatory guidelines governing clinical investigation. As part of our K12 initiative, we plan to expand our unique and highly successful, cross-disciplinary Biodesign program. In addition, we will initiate the Advanced Residency Training Program at Stanford (ARTS), affording MD clinical fellows the opportunity to pursue a PhD in a research area that complements their clinical interests and fosters translation of new discoveries to clinical medicine. PHS 398/2590 (Rev. 09/04. Reissued 4/2006) Page 594 Continuation Format Page Principal Investigator/Program Director (Last, First, Middle): Greenberg, Harry B. Aim 5. To centralize and coordinate Stanford CTR education, training, and career development programs. We plan to create a CTR Education and Training Coordinating Office to provide oversight and efficient management of all of our programs, on behalf of all levels of trainees. This office will be responsible for maintaining a database of students and clinical research personnel who are interested in participating in any of our education and training programs. A comprehensive and centralized mentoring program will be developed, in coordination with the Council of Mentors in the CTRU (Program Function 4) and the Center for Innovative Study Design (CISD;Program Function 1). Finally, with the assistance of the Translational Informatics Program (Program Function 2), a database will be developed that will include all mentors and trainees in CTR along with descriptions of their research interests. This will be used for matching mentors and trainees in addition to tracking and evaluating the program. The CTR office will serve as a single source of information for seminars, courses, training programs, and existing opportunities to join interdisciplinary clinical and translational science research teams. In addition to tracking all existing opportunities to participate in research projects, this office also will be responsible for developing and overseeing our innovative multidisciplinary. design team exercises. These exercises will afford all trainees the chance to work in a team environment. Through this centralized and coordinated effort, any gaps in CTR education and training will be identified and addressed in a timely manner. Importantly, the CTR office that we envision will foster synergies by bridging Stanford's academic and clinical enterprises, linking investigators, faculty, students, trainees, clinicians, and affiliated students who share a commitment to CTR education, training, and research. The CTR office also will serve to coordinate and expand several successful Stanford University and SoM education and training programs designed to expose low-income and gifted high school students to CTR. This will (1) stimulate long-term interest in a career in the biological sciences or medicine, thereby expanding the pipeline of available investigators, (2) prepare the students for the transformation of biomedical research, which increasingly focuses on team-based, interdisciplinary efforts, and (3) encourage a more diverse CTR workforce. C. BACKGROUND C.1. Progress to Date During the past five years, we have taken important steps towards enhancing and expanding the education, training, and career development of clinical and translational investigators at Stanford. Our next step is to create a seamless and fully integrated program that is accessible to all levels of trainees from across our University and Medical Center. Furthermore, we will use our success at building meaningful multidisciplinary collaborations (e.g., Biodesign Program) to formally frame other synergies between the wealth of programs that exist across Stanford's seven discipline-specific Schools and 15 Interdisciplinary Centers (see Overall Approach section). The formation of SCCTER will allow us to build an academic home and facilitate the integration of our educational programs, while enhancing accessibility and coordination and assuring long-term and sustained success on behalf of our continuum of professionally diverse trainees. Some of the key educational initiatives that have been developed at Stanford include high school scientific enrichment programs, a multidisciplinary Biodesign effort to teach innovation and inventorship, the Scholarly Concentration program for medical students, and a Masters of Science in Medicine degree opportunity for PhD candidates. We also have expanded the breadth and depth of short courses in clinical research for ail members of our clinical and translational research community, including MD and PhD students, clinical (MD) and basic science (PhD) postdoctoral trainees, clinical research nurses, research associates, and faculty across the University. The expansion of these educational efforts and the integration of these current and proposed efforts into a coordinated CTR training and career development program under SCCTER is described below. C.2. Institutional Commitment Stanford University is committed to multidisciplinary education and research programs that enhance collaboration across the University. In 2004, our University President, John Hennessy, formed a Commission on Graduate Education (CGE) to review graduate programs and consider how Stanford could continue to evolve graduate education in light of the changing challenges and opportunities facing our PHS 398/2590 (Rev. 09/04, Reissued4/2006) Page 595 Continuation Format Page Principal Investigator/Program Director (Last, First, Middle): Greenberg, Harry B. graduate students. In his charge to this Commission, President Hennessy stated: "Our challenge as a leading educational institution is to prepare our graduates to be leaders in finding solutions for the large- scale, complex problems of the 21st century. Dealing with the issues of our day, such as globalization, the impact on society of rapid scientific and technological advances, emerging and chronic health care problems, and the effects of human activities on the environment, demands new approaches that are creative, collaborative, and multidisciplinary." A report of the Commission delivered to the University Senate in the spring of. 2006 concluded that our graduate education programs, in addition to providing students with deep and rich disciplinary expertise, needed to offer both students and faculty ample opportunities (and incentives) to "interact with a diverse group of colleagues from across the University, building networks of contacts who can assist them while at Stanford and throughout their careers and to develop the knowledge and skills needed to be effective leaders in their chosen fields." Stanford has embraced this interdisciplinary approach and is poised to both support the training of individuals interested in pursuing academic careers as CTR investigators across the enterprise and to utilize the resources throughout Stanford to educate CT researchers. In parallel, the leaders of our non medical professional Schools have encouraged their students to engage in some of the research and training opportunities at the SoM. For example, engineering and business students actively participate in the Biodesign research teams;law students matriculate with medical students in a biomedical ethics certificate program;and undergraduate students frequently participate in CTR projects under the direction of faculty members from the SoM. These efforts by the Commission on Graduate Education are well-aligned with the SoM comprehensive strategic plan, Translating Discoveries, which has put translational research as its foremost research mission and education as its centerpiece. Evidence that our School is committed to facilitating CTR and the education of CTR investigators includes: [unreadable] Aligning the leadership of medical education at the SoM with oversight of the CTR education and training programs, by the appointment of Charles Prober, MD, as Senior Associate Dean for Education. [unreadable] Revision of the medical school curriculum to include required scholarly concentrations, including concentrations focused on translational, clinical, and health services research. [unreadable] Funding the Medical Scholars Program, which provides support for medical students to pursue hypothesis-driven research projects ranging in duration from three months to one year. [unreadable] Making Master degrees in Epidemiology and Health Services Research accessible for undergraduates, medical students, graduate students in other disciplines, and postdoctoral fellows. [unreadable] Approval of Masters of Science in Medicine program for PhD students. [unreadable] Allowing students from other schools to attend courses offered through theSoM D. PROGRAM DESCRIPTION Because translational medicine is inherently both interdisciplinary and multidisciplinary in nature, a comprehensive CTR education program should include trainees from both the MD and PhD pathways, should work towards filling the gaps in each pathway, and should integrate these programs so that trainees receive maximum exposure to other disciplines and to each other. Our goal is to create a fully integrated, University-wide, CTR community that stimulates and educates all levels of trainees interested in investigational careers focused on human health. The continuum of trainees extends from students participating in our high school summer programs to faculty supported by NIH Mentored Patient-Oriented and Clinical Scientist Research Career Development Awards (K23 &K08,respectively). Trainees along this continuum include: high school students interested in biomedical careers;Stanford University undergraduates interested in careers in medicine (premedical students), basic biology, or other health related disciplines like public health or health policy;medical students focused on future academic careers in clinical and translational science;PhD students pursuing advanced training in a biological science;MD residents and fellows;PhD postdoctoral fellows seeking training that enhances their ability to work on multidisciplinary translational research teams;and a variety of other professionals such as law, psychology, anthropology, economics, and business students with an interest in health related issues. The CTSA will coordinate oversight of our existing programs serving this broad spectrum of trainees and the development of several new advanced degree programs. A map of the various didactic and programmatic PHS 398/2590 (Rev. 09/04, Reissued 4/2006) Page 596 Continuation Format Page Principal Investigator/Program Director (Last, Rrst,Middle): Greenberg, Harry B. ClinicalMedicine Education and Training Residency/Fellowship JuniorFaculty MS,PhD: Epidemiology or MENTORING / RESEARCH DATABASE CCIS CTR EDUCATION &CAREER DEVELOPMENT TRAINING^W Stanford at o TRANS-UNIVERSITY INTERDISCIPLINARY RESEARCH TEAMS m the Tech Biology High School Undergraduates Basic Science Research Education and Training Figure 8.1.Overview of the continuum of education reached by the efforts in the Educational component of SCCTER. The continuum of MD, PhD and other students and trainees are depicted along the top and bottom of the figure, respectively. Mentors support trainees at all levels and in all disciplines;allied health personnel represent key members of our research teams. The corresponding Specific Aims (numbers), or Program Functions (Ethics Core, EC;Support Portal, SP;Career Development and Diversity (CDD), and programs (T32, K12) are indicated. elements at each level of the training continuum is shown in Figure8.1. The rich array of courses, symposia, seminars, workshops (Table 8.2), and advanced degrees available to trainees interested in CTR will be complemented by practical training as members of interdisciplinary CTR teams, supported by mentors with expertise in clinical and translational research, biostatistics, and epidemiology. Since Stanford University does not have Schools of nursing, dentistry, public health, or pharmacy, our approach to education of these critical partners in the CTR enterprise will be distinct from many other CTSA efforts. These allied health professionals will have access to all of our training and career development opportunities and will be key members of our research teams. Career development and training opportunities will include areas such as leadership (Program Function 11: Career Development and Diversity), ethics (Program Function 7: Ethics), and regulatory issues (Program Function 3: Support Portal). Furthermore, a database of mentors and trainees and their research will be available for mentor matching. SCCTER will support enhanced coordination and oversight of our existing programs serving this spectrum of trainees and the development of several advanced degree programs focused on expanding the pipeline of clinical and translational scientists. The integration and coordination of these disparate educational programs will be transformative at Stanford, where a concerted effort to link health related issues across multiple disciplines and all levels of training has not existed previously. This effort is described below. Aim 1 is a broad aim designed to focus the vast expertise present at all of Stanford's seven Schools and its various Independent Centers on the challenge of educating the next generation of CT investigators. Aims 2-4 of our program are sequentially organized according to the progression of trainees along their educational pathway. Aim 2 focuses on MD and PhD predoctoral students (T32), Aim 3 on MD residents, PHS 398/2590 (Rev.09/04,Reissued4/2006) Page 597 Continuation Format Page